Developing the Vaccine: A Race to Save Lives

By: Christie Peng and Shalini Ballur

Creating a vaccine in a short amount of time is no easy task for scientists as making a vaccine usually takes several years because of strict policies on ensuring that the vaccines are safe to use. There is a series of guidelines and stages they must meet to develop a vaccine. According to the CDC, the stages of this cycle are the exploratory stage, pre-clinical stage, clinical development, regulatory review and approval, manufacturing, and quality control. One of these stages takes months and months of trial and error, taking up the most time. The clinical development stage consists of three phases. In the first phase, Phase 1, the vaccine is tested on a small group of people. All of these volunteers must show some sort of immune response for the next phase to begin. In the second phase, the vaccine is given to those who exemplify certain characteristics matching the ones the vaccine is made for. In the final phase, Phase 3, the vaccine is given to an even wider range and number of people to make sure the vaccine is safe to give to the public.

A vaccine is developed using a series of steps in a particular order. The first step is to generate the antigen in order to induce an immune response. By inducing a response, the pathogen is harvested and generates a recombinant protein. Next, the antigen is released from the cells and isolated from the material used in it’s growth. This is required to release as much virus or bacteria as possible. The third step is to purify the antigen using chromatography- a method of separating materials. Following the purification process, the addition of an adjuvant (a material that nonspecifically enhances immune responses) may be added to the vaccine. In addition, vaccines can include stabilizers or preservatives to prolong shelf-life. Finally, all of the components that contribute to the creation of the final vaccine are mixed uniformly in a single vessel. The vaccine is filled into vials or syringe packages, sealed with sterile stoppers and plungers, and labeled for widespread distribution. Vaccines can be freeze dried and then rehydrated when administered to patients.

At the moment, Moderna, a biotechnology company, has advanced to Phase 3. Their Phase 3 plan consists of testing their vaccine on 30,000 volunteers and put them in high risk areas of infection. The participants will be split into two groups, where the first group will receive 100 micrograms of the vaccine in two doses, each a month apart. The second group will do the same but with placebo. This will be used to compare the effectiveness of the first group. Moderna’s Phase 1 included testing 45 adults. These volunteers were given two doses of the mRNA-1237 vaccination. The reason for this is because the first vaccination acts as a primer, setting up the body’s immune system. The two doses were given about a month apart. Different amounts of doses were given to each volunteer and symptoms like fatigue, headaches, muscle pain, and chills were common. With the creation of the vaccine, the antibody count increased to the same amount that recovered coronavirus patients have. The antibodies help in preventing the virus from attacking cells and replicating their material.

If Moderna passes this final phase, we will be looking forward to new vaccines becoming available some time next year. Dr. Paul Offit, a director of the Vaccine Education Center and a physician in the Division of Infectious Diseases at the Children’s Hospital of Philadelphia states, "we know that it's safe in 45 people, which is not going to be the 20 million people or 200 million people who are going to get it here in the United States" which is why creating the vaccine is so meticulous and time consuming. There is also a vaccine product approval process which consists of many steps and is conducted by the FDA. It is a long process which includes the approval of an investigational new drug application, pre-licensure vaccine clinical trials, a biologics license application (BLA), inspection of the manufacturing facility, the presentation of findings to FDA’s Vaccines and Related Biological Products Advisory CommitteeExternal (VRBPAC), and finally the usability testing of product labeling. However, if the vaccine does become available next year, we will not be the first in line. Vaccines will be issued in a certain order: healthline workers, people over the age of 65, and then people who may have a medical illness or condition.

Although we still don’t know everything that’s in the new Covid-19 vaccine, we do know that the vaccine will contain weakened antigens and excipients. Excipients are inactive substances that still serve an important purpose such as stabilizers, preservatives, and adjuvants. Preservatives are found in many beverages and jarred foods, but in vaccines they prevent contamination. Stabilizers keep the vaccine effective during things like transportation and storage. Adjuvants create a stronger immune response in people who receive the vaccine. Other materials used in the manufacturing process of the vaccine but later taken out include antibiotics, cell culture materials, and inactivating ingredients. Antibiotics are used so bacteria doesn’t contaminate the product. Cell culture materials are used to grow vaccine antigens. An example would be egg protein. Inactivating ingredients inactivate toxins and kill viruses. It is most likely that we will be seeing these components in the new coronavirus vaccine.

Citations

Corum, Jonathan, et al. “Coronavirus Drug and Treatment Tracker.” The New York Times, The New York Times, 16 July 2020, www.nytimes.com/interactive/2020/science/coronavirus-drugs-treatments.html?searchResultPosition=6.

Howard, Jacqueline, and John Bonifield. “Moderna Coronavirus Vaccine Shows 'Promising' Results in Published Phase 1 Study.” CNN, Cable News Network, 15 July 2020, www.cnn.com/2020/07/14/health/moderna-coronavirus-vaccine-phase-1-study/index.html.

Mishkin, Shaina. “Moderna's Coronavirus Vaccine Will Be Ready for Distribution in 2021, CEO Says.” Barron's, Barrons, 18 June 2020, www.barrons.com/articles/moderna-coronavirus-vaccine-will-be-ready-for-distribution-in-2021-51592483405.

Vaccine Excipient Summary. Institute for Vaccine Safety at Johns Hopkins University, Feb. 2020, www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/excipient-table-2.pdf.

“Vaccine Testing and Approval Process.” Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, 1 May 2014, www.cdc.gov/vaccines/basics/test-approve.html.